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U.S. Department of Health and Human Services

Product Classification

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Device ultrasound bronchoscope
Regulation Description Ultrasonic pulsed doppler imaging system.
Definition An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs.
Physical State ultrasound bronchoscope
Technical Method An ultrasound bronchoscope has a built-in ultrasound transducer (probe) at the distal end. When used with an ultrasound processor the ultrasound bronchoscope produces ultrasound wave and scans the signals reflected by tissues to generate the ultrasound image.
Target Area bronchial tree and lungs
Regulation Medical Specialty Radiology
Review Panel Ear Nose & Throat
Product CodePSV
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type 510(k)
Regulation Number 892.1550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible